Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-04 @ 12:49 AM
Study NCT ID:
NCT07296393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin A in Cord Blood and Preterm Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite adverse neonatal outcome (any of death, moderate-severe BPD, NEC≥stage II, IVH≥grade III, ROP≥stage 3, PVL, hsPDA, culture-proven sepsis)', 'timeFrame': "From birth to 36 weeks' PMA or discharge, up to 3 months chronological age."}]}, 'conditionsModule': {'conditions': ['Extremely Premature Infant']}, 'referencesModule': {'references': [{'pmid': '30500928', 'type': 'RESULT', 'citation': 'Allen LH, Miller JW, de Groot L, Rosenberg IH, Smith AD, Refsum H, Raiten DJ. Biomarkers of Nutrition for Development (BOND): Vitamin B-12 Review. J Nutr. 2018 Dec 1;148(suppl_4):1995S-2027S. doi: 10.1093/jn/nxy201.'}]}, 'descriptionModule': {'briefSummary': "This single-center prospective cohort study aims to describe the distribution of umbilical-cord blood vitamin A concentrations in extremely preterm infants (\\<32 weeks' gestation) and to evaluate whether low cord blood vitamin A is associated with increased risk of neonatal morbidities such as bronchopulmonary dysplasia (BPD), necrotising enterocolitis (NEC), severe intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP), periventricular leukomalacia (PVL), high-grade patent ductus arteriosus (hsPDA), respiratory distress syndrome (RDS), sepsis and death before discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm neonates (gestational age \\<32 weeks)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGestational age \\<32 weeks Birth at First Hospital of Jilin University Umbilical cord blood sample obtained within 24 h Parental written informed consent\n\nExclusion Criteria:\n\nMajor congenital malformation or chromosomal abnormality Refusal of consent'}, 'identificationModule': {'nctId': 'NCT07296393', 'briefTitle': 'Vitamin A in Cord Blood and Preterm Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'The Association Between Umbilical Cord Blood Vitamin A Levels and Adverse Outcomes in Extremely Preterm Infants: A Single-Center Prospective Cohort Study', 'orgStudyIdInfo': {'id': '25K281-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extremely Preterm Infants'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hui Wu', 'role': 'CONTACT', 'email': 'wuhui@jlu.edu.cn', 'phone': '13134318877'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}